K173490
Substantially EquivalentAmsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
- Applicant
- STERIS Corporation
- Product code
- FLE
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, US
Adverse events under product code FLE
product code FLE- Malfunction
- 444
- Total
- 444
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.